Efficacy Study of Oral Nicorandil on Improving Microvascular Function in Female Non-obstructive Coronary Artery Disease (CAD) Participants

NCT03010423 | Terminated Phase 4 Results

• 1 other identifier: EMR200505_506
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a single-center, interventional, pilot study to evaluate the improvement of microvascular function by positron emission tomography (PET) after twelve-week treatment of oral nicorandil in female non-obstructive CAD Participants.

Conditions

Non-obstructive Coronary Artery Disease

Keywords

Non-obstructive coronary artery disease; Nicorandil

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Myocardial Blood Flow Reserve (MFR) by Stress Positron Emission Tomography (PET) at Week 12

  Myocardial blood flow reserve is a measure of endothelial function measured by positron emission tomography.

  Baseline, Week 12

Secondary Outcomes (7)

• Change From Baseline in Myocardial Blood Flow (MBF) by Rest Positron Emission Tomography (PET) at Week 12

  Baseline, Week 12

• Change From Baseline in Myocardial Blood Flow (MBF) by Stress Positron Emission Tomography (PET) at Week 12

  Baseline, Week 12

• Change From Baseline in Ejection Fraction at Week 12

  Baseline, Week 12

• Change From Baseline in Left Ventricular End-Systolic Dimension (LVESD) at Week 12

  Baseline, Week 12

• Change From Baseline in Left Ventricular Wall Thickness at Week 12

  Baseline, Week 12

Study Arms (1)

Nicorandil

EXPERIMENTAL

Drug: Nicorandil

Interventions

Nicorandil DRUG

Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.

Nicorandil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Participants aged 18-70 years
• Participants with typical stable angina but without coronary obstruction (defined as coronary occlusion less than (\<) 50%) by invasive coronary angiography or coronary computed tomography angiography (CTA) in recent three months
• All other long acting cardiovascular disease medicines, including but not limited to aspirin/clopidogrel, calcium channel blockers (CCB), Angiotensin-converting enzyme inhibitors (ACEI)/Angiotensin II Receptor Blockers (ARB), beta-blockers, statins, ivabradine, trimetazidine, et al, should be stable taken for at least two weeks before screening period
• For participants who met these four criteria above, MFR will be tested by stress PET. Participants whose MFR \<3.0 could be included in the study

You may not qualify if:

• Severe or uncontrolled hypertension (resting Systolic blood pressure \[SBP\] \>=160 millimeter of mercury (mmHg), or resting Diastolic blood pressure \[DBP\] \>=100mmHg at screening period)
• Participants with shock (including cardiogenic shock), or hypovolemia
• Severe hypotension (resting SBP\<90mmHg，or resting DBP\<60mmHg)
• Significant valvular heart disease, congenital heart disease or cardiomyopathy
• Congestive heart failure(New York Heart Association \[NYHA\] III-IV), echocardiographic ejection fraction\<45%
• Acute pulmonary edema;
• Hepatic or renal dysfunction, defined as:
• Serum Alanine Aminotransferase (ALT) \> triple of the normal value upper limit;
• Serum Aspartate Aminotransferase (AST) \> triple of the normal value upper limit
• Serum creatinine \> twice of the normal value upper limit
• Glaucoma
• Active peptic ulcer or active skin ulcer
• Taking glyburide, phosphodiesterase type 5 (PDE-5) inhibitor, soluble guanylate cyclase stimulator(s)
• Known to be hypersensitivity to nicorandil, nitrates, niacin, or any of the excipient
• With contraindication to complete stress PET test

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Co., Ltd., China: collaborator

Study Sites (1)

Peking union medical college hospital

Beijing, China

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Interventions

Nicorandil

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The study was terminated early and due to the lack of approval of data exportation from the Office of Human Genetic Resource Administration (OHGRA) China, the data could not be extracted. Therefore, no data available for the analyses.

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Serono Co., Ltd., China

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: November 30, 2016
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-06

Locations

CN (1)